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Phase II Study of Oxaliplatin And Fixed Rate Infusion Gemcitabine as Second Line Therapy for Patients With Metastatic Colon Cancer

Phase 2
18 Years
Not Enrolling
Colorectal Cancer

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Trial Information

Phase II Study of Oxaliplatin And Fixed Rate Infusion Gemcitabine as Second Line Therapy for Patients With Metastatic Colon Cancer



- Determine the complete response and partial response rates in patients with recurrent
or progressive colon cancer treated with gemcitabine hydrochloride and oxaliplatin.


- Determine the overall and failure-free survival of patients treated with the
chemotherapy regimen.

- Determine the duration of response (complete or partial) in patients treated with this

- Determine the percentage of patients who experience a 50% fall of serum
carcinoembryonic antigen levels with a baseline elevation of > 5 U/mL after receiving
this regimen.

- Evaluate the toxicity associated with the administration of this regimen in these

OUTLINE: This is a non-randomized study.

Patients receive gemcitabine hydrochloride IV over 100 minutes on day 1 and oxaliplatin IV
over 2 hours on day 2. Courses repeat every 2 weeks in the absence of disease progression or
unacceptable toxicity.

After completion of study treatment, patients are followed periodically for up to 1 year.

PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study.

Inclusion Criteria


- Histologically or cytologically confirmed adenocarcinoma of the colon

- Metastatic or recurrent disease

- Redocumentation of tumor histology or cytology prior to protocol therapy is not
required if documented tumor was confirmed prior to initial therapy

- Measurable disease

- Lesion of ≥ 1 cm in longest diameter that can be repetitively assessed by
radiographic measurement or any lesion of ≥ 2 cm in longest diameter that can be
repetitively assessed by physical examination

- Positive bone scans, osteoblastic or osteolytic bone lesions, pleural effusions,
and positive bone marrow biopsies are not considered measurable or evaluable

- Metastatic disease to the brain allowed if emergent radiotherapy for symptomatic CNS
disease is not required

- Must have received at least one prior chemotherapy regimen (with or without

- One of the prior regimens must include irinotecan hydrochloride, fluorouracil,
and leucovorin calcium or irinotecan hydrochloride and other fluoropyrimidine

- Previous therapy with C-225 and/or bevacizumab is allowed

- .


- ECOG performance status 0-2

- Granulocyte count ≥1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Creatinine ≤ 2.0 mg/dL

- Bilirubin < 1.5 mg/dL

- SGOT ≤ 2 times upper limit of normal (ULN)

- Alkaline phosphatase < 2.5 times ULN

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No serious medical or psychiatric illness that would render chemotherapy unsafe

- No concurrent clinically evident malignancy except inactive nonmelanoma skin cancer,
low-grade low-stage bladder carcinoma followed off therapy, or lobular neoplasia of
the breast

- No clinical AIDS or known positive HIV serology


- See Disease Characteristics

- Recovered from prior therapy

- No investigational agent for at least 30 days prior to study entry

- No chemotherapy within the past 3 weeks

- No radiotherapy for palliation within the past 2 weeks prior to study entry

- No prior oxaliplatin or gemcitabine hydrochloride

- No concurrent participation in another clinical trial

- No other concurrent anticancer therapy including chemotherapy, radiotherapy, hormonal
therapy, or immunotherapy

- No other concurrent investigational drugs

Type of Study:


Study Design:

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response Rate as Measured by RECIST Criteria

Outcome Description:

Complete Response (CR) or Partial Response (PR) as defined by RECIST v 1.0 criteria.

Outcome Time Frame:

4 - 6 months

Safety Issue:


Principal Investigator

Caio Max S. Rocha Lima, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Miami Sylvester Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

September 2005

Completion Date:

May 2008

Related Keywords:

  • Colorectal Cancer
  • adenocarcinoma of the colon
  • recurrent colon cancer
  • stage IV colon cancer
  • Colonic Neoplasms
  • Colorectal Neoplasms



University of Miami Sylvester Comprehensive Cancer Center Miami, Florida  33136